Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms

N/AActive Not RecruitingNCT02489539

W.L.Gore & Associates175 enrolled

Overview

The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.

The study design is a prospective, nonrandomized, international, multicenter study comprised of two parallel substudies. The total subject population is 175 subjects with 80 subjects assigned to the Short Neck Substudy and 95 subjects to the High Neck Angulation Substudy. This clinical study will include up to fifty-six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams and contrast-enhanced computed tomography (CT) scans at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Conformable AAA Endoprosthesis implant. Each Substudy will be evaluated and reported independently from each other according to the Safety and Effectiveness Endpoints. No comparative analyses between these substudies are planned.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

175

Conditions

Aortic Aneurysm, Abdominal

Interventions

GORE® EXCLUDER® Conformable AAA EndoprosthesisDEVICE

Endovascular Aneurysm repair (EVAR) is a minimally invasive procedure designed to exclude an aneurysmal segment of the aorta from blood circulation. The EVAR procedure involves delivery of a stent- graft compressed onto a catheter to an aneurysmal segment of the aorta from a remote access site, generally the femoral artery. Arterial access may be done by either percutaneous or cut-down technique.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. AAA meeting any of the following criteria: * Maximum diameter ≥50 mm * Rapid growth (\>5 mm in a 6 month period) * Non-ruptured AAA presenting with clinical symptoms 2. Adequate anatomy to receive the GORE® EXCLUDER® Conformable AAA Endoprosthesis, including: * Adequate iliac / femoral access * Infrarenal aortic neck diameter 16-32 mm * Infrarenal aortic neck length ≥10 mm * Aortic neck angle ≤ 90˚ * Distal iliac artery seal zone ≥10 mm * Iliac artery diameter 8-25 mm 3. An Informed Consent Form (ICF) signed by Subject 4. Male or infertile female 5. Able to comply with Protocol requirements including following-up 6. Life expectancy \> 2 years 7. Age ≥ 21 years Exclusion Criteria: 1. Mycotic or ruptured aneurysm 2. Known concomitant thoracic aortic aneurysm which requires surgical intervention 3. Renal insufficiency defined as creatinine \> 2.5 mg/dL or patient undergoing dialysis 4. New York Heart Association (NYHA) class IV 5. Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s) 6. Severely tortuous or stenotic iliac and / or femoral arteries 7. Patient has body habitus or other medical condition which prevents adequate delineation of the aorta 8. Participating in another investigational device or drug study within 1 year of treatment 9. Systemic infection which may increase the risk of endovascular graft infection 10. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome 11. Planned concomitant surgical procedure or major surgery within 30 days of treatment date 12. Known history of drug abuse 13. Known sensitivities or allergies to the device materials

Locations (51)

Outcomes

Primary Outcomes

Number of Subjects Free From Primary Safety Endpoint Event

The primary safety endpoint event includes a composite of the following: * Death * Stroke * Myocardial Infarction * Bowel Ischemia * Paraplegia * Respiratory Failure * Renal Failure * Procedural Blood Loss \> 1000 mL * Thromboembolic events (including limb occlusion and distal embolic events)

Time frame: 30 Days

Number of Subjects With Device Treatment Success

The Primary Effectiveness Endpoint of device treatment success is a composite of technical success (successful access and deployment of all required GORE® EXCLUDER® Conformable AAA Endoprosthesis components) and freedom from: * Type I endoleak in the 12 month window * Type III endoleak in the 12 month window * Migration (10 mm or more) at the 12 month window (relative to post-operative baseline) * AAA enlargement ≥5 mm with or without intervention at the 12 month window (relative to post-operative baseline) * AAA rupture through the 12 month window * Conversion to open repair through the 12 month window

Time frame: 12 Months

Secondary Outcomes

Number of Subjects With Reintervention

Defined as an adverse event treatment performed to either treat the abdominal aneurysm and/or device-related complication (Adjudicated by independent Clinical Events Committee)

Time frame: 5 years

Number of Subjects With Stent Fracture

Defined as fracture of the wire used to construct the stent (assessed by independent 3rd party imaging laboratory)

Time frame: 5 years

Number of Subjects With Type II Endoleak

Defined as an endoleak arising from a patent branch vessel perfusing the aneurysm, e.g., lumbar or inferior mesenteric branch. (assessed by independent 3rd party imaging laboratory)

Time frame: 5 years

Data from ClinicalTrials.gov

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Mayo Clinic Arizona

Phoenix, Arizona, United States

University of Southern California

Los Angeles, California, United States

Leland Stanford Junior University

Stanford, California, United States

River City Clinical Research

Jacksonville, Florida, United States

Baptist Cardiac and Vascular Institute

Miami, Florida, United States

Florida Hospital

Orlando, Florida, United States

Sarasota Vascular Specialists

Sarasota, Florida, United States

Emory University

Atlanta, Georgia, United States

Vascular Surgical Associates, PC

Marietta, Georgia, United States

...and 41 more locations

Number of Subjects With Aneurysm-related Mortality

Defined as a composite of the following: death within 30 days or in hospital from initial procedure, death due to rupture of the originally treated aneurysm and death within 30 days or in hospital following a procedure to treat the originally treated aneurysm. (Adjudicated by independent Clinical Events Committee)

Time frame: 5 years

Number of Subjects With Significant Index Procedure Blood Loss

Defined as estimated blood loss recorded during the endovascular procedure \> 1000 mL

Time frame: Procedure Day

Number of Subjects With Type IV Endoleak

Defined as Endoleak of whole blood through the graft fabric (Graft Porosity). (assessed by independent 3rd party imaging laboratory)

Time frame: 5 years

Median Hospital Stay

Defined as time to discharge for initial procedural hospitalization

Time frame: Through initial hospital discharge

Median Index Procedure Time

Defined as time from first arterial access in the groin to the closure of the final access vessel

Time frame: Procedure Day

Number of Subjects With Severe Stroke

Defined as stroke resulting in severe impairment or fatal outcome (Adjudicated by independent Clinical Events Committee)

Time frame: 5 years

Number of Subjects With Severe Myocardial Infarction

Defined as myocardial Infarction resulting in severe hemodynamic dysfunction necessitating resuscitation, cardiac arrest, or fatal outcome. (Adjudicated by independent Clinical Events Committee)

Time frame: 5 years

Number of Subjects With Severe Bowel Ischemia

Defined as bowel Ischemia resulting in bowel resection or fatal outcome (Adjudicated by independent Clinical Events Committee)

Time frame: 5 years

Number of Subjects With Severe Paraplegia

Paraplegia resulting in major permanent deficit (Adjudicated by independent Clinical Events Committee)

Time frame: 5 years

Number of Subject Deaths

Defined as death of any cause (all-cause mortality)

Time frame: 5 years

Number of Subjects With Severe Renal Failure

Defined as renal failure resulting in permanent dialysis, transplant, or fatal outcome (Adjudicated by independent Clinical Events Committee)

Time frame: 5 years

Number of Subjects With Severe Respiratory Failure

Defined as respiratory failure resulting in prolonged intubation (\> 48 hours), tracheostomy, deterioration in pulmonary function, new onset O2 dependence, or fatal outcome (Adjudicated by independent Clinical Events Committee)

Time frame: 5 years

Number of Subjects With Thromboembolic Events (Including Limb Occlusion and Distal Embolic Events)

Defined as ischemic events from tissues distal to the device implantation site (lower extremity, buttock, etc.) and that are a direct result of an occlusion within the device or sufficiently debilitating to necessitate bypass, open surgical repair, or limb amputation (Adjudicated by independent Clinical Events Committee)

Time frame: 5 years

Number of Subjects With Type I Endoleak

Defined as endoleak arising from the proximal (Type IA) or distal (Type IB) sealing zone of the device perfusing the aneurysm. (assessed by independent 3rd party imaging laboratory)

Time frame: 5 years

Number of Subjects With Type III Endoleak

Defined as endoleak arising from the component junction(s) of the prosthesis or due to damage to the graft material (assessed by independent 3rd party imaging laboratory)

Time frame: 5 years

Number of Subjects With Migration

Defined as prosthesis and/or intercomponent migration (10 mm or more) relative to post-operative baseline (assessed by independent 3rd party imaging laboratory)

Time frame: 5 years

Median Procedural Blood Loss (mL)

Median blood loss at index procedure

Time frame: Procedure Day

Number of Subjects With AAA Enlargement ≥5 mm

Defined as AAA enlargement ≥5 mm (with or without reintervention) relative to post-operative baseline (assessed by independent 3rd party imaging laboratory)

Time frame: 5 years

Number of Subjects With Abdominal Aortic Aneurysm Rupture

Defined as rupture in the treated segment of the aorta verified with direct observation or CT scan

Time frame: 5 years

Number of Subjects With Conversion to Open Repair

Defined as open surgical abdominal aneurysm repair necessitating the explant of the stent-graft and abdominal aortic reconstruction (Adjudicated by independent Clinical Events Committee)

Time frame: 5 years

Technical Success

Successful access and deployment of all required CEXC device components, comprised of all the following: * Successful access * Successful deployment of Device endoprostheses in the intended anatomical location * Successful removal of all device delivery catheters from the patient * Patent Device components on completion angiography * Absence of Type I or Type III endoleak on completion angiography * Successful access site closure

Time frame: Procedure Day